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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SIG HP REV TC3 BOX TRIAL SZ5; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC.1818910 SIG HP REV TC3 BOX TRIAL SZ5; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 201103015
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the office set sig hp rev tc3 box trial sz5 broke.
 
Additional Manufacturer Narrative
Examination of the submitted device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
SIG HP REV TC3 BOX TRIAL SZ5
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6973852
Report Number1818910-2017-27359
Device Sequence Number10887162
Product Code LXH
UDI-Device Identifier10603295081364
UDI-Public10603295081364
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Catalogue Number201103015
Device Lot NumberSO2002022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Initial Date Received by Manufacturer 09/26/2017
Supplement Date Received by Manufacturer10/31/2017
Initial Report FDA Received Date10/24/2017
Supplement Report FDA Received Date11/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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